Orthostatic, Respiratory, Balance-Intervention

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Inspiratory Muscle Training (IMT)

• Registration Number: NCT04210063
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-13
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Primary Completion: 2020-07-29
• Study Completion: 2020-07-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Upper/lower/both extremity weakness or paralysis resulting from SCI with ASIA Impairment Scale (AIS) grades A-C who use a wheelchair as primary means of mobility.
2. ≥1 year post-injury
3. Willingness to participate in the study and provide consent.

Exclusion Criteria

1. Inability to understand the consent form or consent process

2. Reliance on a mechanical ventilator.

3. Use of Betablockers

4. Inability to travel to The Miami Project for weekly sessions during intervention month

5. Any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to:

   • Fracture, dislocation, or malformations affecting supine or sitting tolerance.
   • Spinal instability.
   • Pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine.

6. Individuals who are able to stand independently or with a walker

7. Unresolved deep vein thrombosis (DVT).

8. Hospitalization due to autonomic dysreflexia in the last 3 months.

9. Pregnancy determined by urine testing in sexually active females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMT Intervention	Inspiratory Muscle Training (IMT)	During the first month, participants will be in a month-long control wash in period where no intervention will be provided. During the second month, participants will be in a 4-week daily IMT intervention period. During the third month, participants will be in a month-long efficacy period with no intervention provided.

Primary Outcome Measures

Name	Time	Method
Sustained Maximal Inspiratory Pressure (SMIP)	Week 12	SMIP measured in pressure-time units (PTU) will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)	Week 12	rMSSD, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Functional Seated Balance	Week 12	Functional Seated Balance will be measured using the Function in Sitting Test for SCI (FIST-SCI). FIST-SCI consist of 14 different standardized seated balance tasks and scored on a 5-point ordinal scale from 0-4. A higher score indicates increased independence.
Quality of Life (QoL)	Week 12	QoL will be measured using the Quality of Life Index, SCI version (QOLI-SCI). QOLI-SCI is a set of two 37-items questionnaire with total scores ranging from 74 to 444 with the higher score indicating increased quality of life.
Independence	Week 12	Independence will be measured using the Spinal Cord Independence Measured (SCIM). SCIM has a total score ranging from 0-100 with the higher score indicating increased independence.
Percent Compliance of Training Sessions	4 weeks	Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days.
Percent Compliance of Training Minutes	4 weeks	Feasibility of the IMT protocol will also be reported as the percentage of completed total time out of the 840 minutes total expected session minutes(30 minutes daily for 28 days).
Maximal Inspiratory Pressure (MIP)	Week 12	MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop
Standard deviation of normal R-R intervals (SDNN)	Week 12	SDNN, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Systolic Blood Pressure (SBP)	Week 12	Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.

Secondary Outcome Measures

Name	Time	Method
Maximal Expiratory Pressure (MEP)	Week 12	MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device.
Inspiratory Duration (ID)	Week 12	ID measured in seconds will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Forced Vital Capacity	Week 12	FVC, evaluated in liters, will be measured using a handheld digital spirometer device.
Forced Expiratory Volume in one Second (FEV1)	Week 12	FEV1, evaluated in liters, will be measured using a handheld digital spirometer device.
Peak Expiratory Flow (PEF)	Week 12	PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device.
Heart Rate Variability (HRV) Frequency	Week 12	Low Frequency (LF) and High Frequency (HF) Power, reported in percentage, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Diastolic Blood Pressure (DBP)	Week 12	Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.

Trial Locations

Locations (1)

The Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States